Tomsk

This research aims to provide continued access to study treatments for participants with pulmonary hypertension who have completed previous clinical studies but have no other way to receive these treatments. It focuses on assessing the long-term safety of the study drugs macitentan, selexipag, and a fixed dose combination of macitentan and tadalafil. The study is designed for participants who benefited from these treatments during parent studies and have no alternative approved therapies available. Participants will continue receiving oral study drugs macitentan once daily with doses adjusted for children by weight, selexipag twice daily with dosing based on previous maintenance dose and body weight for children, or a fixed dose combination of macitentan and tadalafil once daily. Adults will have study visits every six months, while pediatric participants will have visits every three months. These visits will collect information on the treatments safety and effectiveness until the participant stops treatment, the drug becomes commercially available, or the study ends prematurely. During the study, participants will undergo regular assessments to monitor safety, including tracking treatment-emergent adverse events, serious adverse events, events leading to discontinuation, and deaths for up to 84 months. Visits will include collecting efficacy and safety data to ensure ongoing monitoring. The overall participation duration may extend for several years, allowing careful observation of long-term effects and safety of these treatments in people with pulmonary hypertension.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

This observational study focuses on adult patients diagnosed with neurofibromatosis type 1 NF1 in Russia. It aims to evaluate clinical characteristics and patient-reported outcomes in routine care settings to better understand the disease manifestations, associated symptoms, and complications in this population. The study is non-interventional and involves collecting data during regular healthcare visits without altering patient treatment. Participants are adults aged 18 years or older with a confirmed diagnosis of NF1 and plexiform neurofibromas PN identified by clinical assessment or imaging methods such as MRI or ultrasound. Patients must have PN-associated symptoms and be either newly diagnosed or nave to MEK-inhibitor therapy. The study does not involve experimental treatments but follows patients receiving standard care to gather clinical and demographic information. During the study, participants undergo evaluations at routine visits where data such as age at NF1 diagnosis, body measurements, symptoms, complications, and disability degree are collected. Imaging results, hospitalizations related to NF1, and medical histories are reviewed. Researchers monitor changes in disability and symptom persistence over time. The study includes assessments of PN volume by MRI and various patient characteristics to understand disease impact and progression. Participation duration aligns with routine care without additional interventions.

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.

Bradyarrhythmias are conditions where the heart beats too slowly, leading to symptoms like dizziness, fainting, and fatigue. These slow heart rhythms can be caused by overactivity of the vagus nerve. This research evaluates two methods of cardioneuroablation CNA, a catheter-based procedure aiming to reduce the effect of this nerve activity as an alternative to permanent pacemakers, especially in younger patients. The study compares focal cryoablation using the Freezor12 Xtra catheter and the standard radiofrequency RF ablation to assess their safety and effectiveness for treating vagally mediated bradyarrhythmias. Participants aged 18 to 60 years with symptomatic bradycardia or vasovagal syncope are assigned to either the RF ablation group or the focal cryoablation group, with 30 patients in each. RF ablation uses a TactiFlex12 SE catheter delivering up to 45W power, while cryoablation uses the Freezor12 Xtra catheter cooled to -750C for 240 seconds per application. Both procedures target ganglionated plexi in the right atrium identified by 3D mapping and spectral analysis. Procedures are performed under intravenous sedation. Participants are monitored at 6 and 12 months after the procedure, including clinical assessments, 12-lead ECG, and 24-hour Holter monitoring. Researchers measure the recurrence of bradyarrhythmias and syncope, changes in heart rate, electrophysiological parameters during the procedure, and any complications such as pericardial effusion or vascular issues. The study lasts up to 12 months of follow-up to evaluate the comparative safety and efficacy of these two CNA techniques.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

Researchers are evaluating the efficacy and safety of treating chronic anal fissure, a painful rupture in the anal canal lasting over two months and resistant to non-surgical treatments. The study compares two treatment approaches botulinum toxin injections and lateral subcutaneous sphincterotomy surgery. The condition mainly affects younger and working-age adults and involves internal sphincter muscle spasm as a key factor. One treatment group receives complex therapy including surgical removal of the fissure without cutting the internal sphincter, followed by injections of Botulinum Toxin Type A directly into the internal anal sphincter at four points. The other group undergoes lateral subcutaneous sphincterotomy, where the internal sphincter muscle is partially cut using a scalpel under anesthesia. Both procedures are performed under spinal anesthesia in a surgical setting. Participants will be monitored for up to 60 days after treatment. Researchers will assess anal sphincter insufficiency, pain intensity at multiple time points, wound healing, sphincter muscle function, temporary disability, and recurrence of the fissure. The study aims to understand differences in treatment effects, including frequency and duration of post-operative incontinence, by comparing these two approaches for chronic anal fissure.